EP0454599A1 - Sehnenbandprothese und Verfahren zur Herstellung - Google Patents

Sehnenbandprothese und Verfahren zur Herstellung Download PDF

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Publication number
EP0454599A1
EP0454599A1 EP91420137A EP91420137A EP0454599A1 EP 0454599 A1 EP0454599 A1 EP 0454599A1 EP 91420137 A EP91420137 A EP 91420137A EP 91420137 A EP91420137 A EP 91420137A EP 0454599 A1 EP0454599 A1 EP 0454599A1
Authority
EP
European Patent Office
Prior art keywords
extracellular
sheath
extracellular matrix
internal
prosthesis according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP91420137A
Other languages
English (en)
French (fr)
Other versions
EP0454599B1 (de
Inventor
Christian Gagnieu
Odile Damour
François Vedel
Christian Echinard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aesculap SAS
Original Assignee
Michel Jean-Pierre
ICP SA
Aesculap ICP SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Michel Jean-Pierre, ICP SA, Aesculap ICP SA filed Critical Michel Jean-Pierre
Publication of EP0454599A1 publication Critical patent/EP0454599A1/de
Application granted granted Critical
Publication of EP0454599B1 publication Critical patent/EP0454599B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/26—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments

Definitions

  • the invention relates to a ligament prosthesis for human or veterinary use, to replace a natural ligament.
  • the prostheses currently described act as artificial ligaments intended to replace or strengthen the injured ligaments.
  • a solution to the first problem is provided in particular by prostheses produced by knitting a high strength polyethylene yarn, sold under the brand RASHEL for example, giving the mesh thus obtained, flexibility and solidity.
  • the second problem is related to a habitation or colonization of the ligament prosthesis consisting in obtaining collagenous, fibroplastic or connective tissue.
  • existing habitable prostheses sometimes made of a biodegradable material, do not induce good quality colonization, which leads to immunological and / or mechanical complications.
  • the interface between the prosthesis and the surrounding tissue consists of an extracellular matrix, collagen-chitosan-glycosaminoglycans, facilitating the development of fibroplasts and the reconstitution of connective tissue.
  • this layer of extracellular matrix on the one hand is biodegradable at the risk of disappearing before the housing has substantially advanced, on the other hand only allows external colonization on the surface of the prosthesis.
  • the present invention provides a ligament prosthesis which solves both the mechanical and biological problems encountered by known prostheses.
  • the prosthesis according to the invention essentially consists of an elongated, flexible and resistant framework and an extracellular matrix covering said framework, the framework being a tubular sheath permeable to the extracellular matrix in the liquid state, said sheath being filled with a matrix dry internal extracellular and covered on the outside by a dry external extracellular matrix, the sheath being crossed by one and / or the other of the two extracellular matrices.
  • extracellular matrix in the present invention is meant an artificial biological extracellular material, originally in the liquid state and in the solid, porous state, after dehydration.
  • the mechanical resistance is provided by the framework
  • the biological performances, for the reconstitution of a normal ligament are provided by the extracellular matrix which arranged on either side of the framework fills and crosses it completely, making colonization quantitatively and qualitatively viable.
  • the sheath is permeable to the liquid extracellular matrix to facilitate the interpenetration of the two extracellular matrices thus drowning the sheath network and then promoting the migration of fibroplasts from one extracellular matrix to the other.
  • the sheath is formed by woven synthetic threads, such as polyterephtaethylene glycol, braided or knitted.
  • the extracellular matrices whose nature is chosen to promote the migration, multiplication and growth of fibroplasts consist of an artificial biological extracellular material, which according to a preferred embodiment of the invention is based on the association of collagen-chitosan-glycosaminoglycans .
  • the extracellular matrices comprise collagen for 60 to 80%, chosen from collagens of type I to XV of human or animal origin, native or without telopeptide, with chitosan for 10 to 30%, the chitosan coming from the N-deacetylation of the chitin of invertebrates and in particular of crabs and by glycosaminoglycans for 6 to 10%, chosen from hyaluronic acid, chondroitin-4-sulfate, chondroitin -6-sulfate, dermatan-sulfate, heparan-sulfate, keratan-sulfate and heparin, these percentages representing a weight concentration relative to the dry weight of the matrix.
  • the extracellular matrices can be chosen from the following materials: crosslinked collagens and derivatives, reacetylated chitosans and derivatives, crosslinked chitosans and derivatives, crosslinked collagen and crosslinked chitosan combination, crosslinked collagen with a chitosan , combination of crosslinked collagen and crosslinked glycosaminoglycans.
  • each of the internal and external extracellular matrices can be respectively the same in identical or different proportions or very different.
  • the object of the present invention is also a method for producing such a prosthesis, that is to say obtaining a perfect impregnation of the tubular sheath by the two internal and external extracellular matrices and good cohesion of the prosthesis thus obtained.
  • the present invention more particularly proposes two methods of manufacturing a prosthesis: a first more specifically adapted to produce prostheses of small diameter and the second preferably adapted to produce prostheses of larger diameter.
  • One of the methods can for example be used for a sheath diameter in particular less than approximately 9 mm, while the other method can be used for a diameter greater than approximately 9 mm.
  • Each of the two methods is discussed below, it being obvious that the numerical values relating to the diameter of the sheath evaluated experimentally, are given by way of non-limiting indication.
  • the method described above has certain drawbacks related to the larger volume of liquid extracellular matrix to be handled. Indeed, on the one hand, after its introduction into the tube and the sheath, the liquid extracellular matrix can spread through the open ends of the tube, and on the other hand, during freezing there is a risk of not freezing any the extracellular matrix, and in particular the heart of the internal extracellular matrix.
  • the ligament prosthesis is constituted by the combination of at least two biocompatible materials shown in Figure 3 respectively in the form of a support or sheath 1 and two internal 2 ′ and external 2 extracellular matrices, biodegradable and determined for allow in vivo the migration, growth and multiplication of cells necessary for the formation of a tissue capable of ensuring the functions of a natural ligament.
  • the extracellular matrix is preferably composed of collagen, chitosan and glycosaminoglycans.
  • this preparation is carried out as follows.
  • a collagen solution is prepared to which a chitosan solution is added which can be obtained by N-deacetylation of chitin extracted from shellfish shells. Then a solution of chondroitin sulfate is added. The viscous solution obtained is then poured into molds suitable for the intended uses, then dehydrated. Note that dehydration of this mixture can be obtained in different ways depending on the applications envisaged and the desired appearance.
  • a mixture is obtained in the form of a felt, the mean pore diameter of which can vary in a controlled manner depending on the operating conditions, in particular the proportion of dry matter in the liquid extracellular matrix, freezing speed and temperature.
  • a film is obtained.
  • the mixture is precipitated with solvents, an extracellular matrix will be obtained in the form of a powder, after grinding the precipitate.
  • the constituents thereof can be added in different proportions corresponding to the above ranges.
  • the extracellular matrix can contain between 0.5 and 2% of dry matter constituted by the three types of molecules mentioned above.
  • the liquid extracellular matrix can contain approximately 1.25% of dry matter constituted by 72% of collagen, 20% of chitosan and 8% of glycosaminoglycans.
  • the mixture obtained is stirred for one hour at a temperature between 20 and 25 ° C, then optionally degassed by ultrasound in particular. Then just dehydrate the mixture.
  • the support or sheath 1 intended to receive the extracellular matrices, as described above, is of the tubular type being shaped to be implanted in place of the natural ligament or ligaments to be replaced.
  • this sheath 1 has any arrangement for its establishment and fixing at the joint considered.
  • the structure of the sheath 1 is not described in detail, since it is not part of the specific object of the invention.
  • the extracellular matrices can be combined with any type of biocompatible sheath whose shapes, dimensions and arrangements make it possible to constitute an artificial ligament.
  • the sheath 1 can be obtained by weaving or knitting fibers of biocompatible material.
  • the sheath is obtained from a weaving of terephtaethylene glycol fibers, without excluding any other compatible polyester capable of being shaped by similar characteristics.
  • the sheath is determined to have the mechanical characteristics, in particular of sufficient tensile strength during the time necessary for the reconstitution of the neoligament under the effect of the action of the extracellular matrix.
  • the nature of the material constituting the sheath 1 is determined so as not to generate reactions inflammatory.
  • the direct test consists in directly depositing a fragment of DACRON + extracellular matrix on a culture of fibroblasts.
  • the culture medium in which the product to be tested has incubated for 48 hours is used.
  • MTT staining transforms the tetrazolium salts into blue formazan crystals and is directly dependent on the activity of the succinate dehydrogenase enzyme.
  • the extracellular matrix was seeded with fibroblasts at the rate of 500,000 cells per cm2 at T o .
  • the culture is incubated at 37 ° C. in an atmosphere containing 5% CO2 in DMEM medium containing 10% calf serum.
  • the medium is changed twice a week. Histological sections are made at T o + 7 days, 15 days, 21 days and 28 days.
  • the fibroblasts have recolonized the extracellular matrix homogeneously at T o + 28 days, as shown in Figure 4.
  • the procedure is carried out in a single step.
  • the sheath 1 is introduced into a tube open at its two ends and the diameter of which is approximately 20% greater than the diameter of said sheath.
  • the extracellular matrix in the liquid state is introduced through one of the openings of the tube at a suitable flow rate to ensure a homogeneous impregnation of the fibers of the sheath.
  • the whole is frozen as indicated above and then subjected to a dehydration operation in the tube or after demolding.
  • this method can also be used in certain cases for the production of ligaments with a diameter greater than 9 mm, but does not make it possible to produce ligaments having differences in terms of composition and texture between the internal extracellular matrix and the external extracellular matrix.
  • the external diameter of the sheath can be 4 to 5 mm, the length of the prosthesis obtained from 10 to 20 cm, its breaking strength of the order of 120 daN and its elongation at break. around 24.4%.
  • a first step after preparation of the liquid internal extracellular matrix, as indicated above, the latter is poured into a cylindrical plastic tube such as polyethylene, polypropylene, polytetrafluorocarbon, silicone, etc. Then the product is frozen. internal extracellular matrix poured into the tube for a time necessary to obtain a stable temperature within said extracellular matrix. The latter is then dehydrated directly in the freezing tube or after demolding.
  • a cylindrical plastic tube such as polyethylene, polypropylene, polytetrafluorocarbon, silicone, etc.
  • the dehydrated internal extracellular matrix 2 ′ is then introduced into the sheath 1 thus constituting a cylindrical body resulting from the introduction of said internal extracellular matrix 2 ′ in the dry state at the interior of said sheath 1.
  • the assembly consisting of the sheath 1 and the internal extracellular matrix 2 ′ in the dry state is introduced into a tube containing a solution of external extracellular matrix in the liquid state and in sufficient quantity to surround the said together in its entirety.
  • the assembly contained in the tube and impregnated with the liquid external extracellular matrix is frozen under the same conditions as those described above. We then proceed to dehydration in the tube or after demolding to obtain the ligament prosthesis.
  • the outside diameter of the support can be 9 to 10 mm, the length of the prosthesis obtained in the range of 25 to 30 cm, its breaking strength in the range of 238 daN and its elongation around 28.4%.
  • This preparation process makes it possible to use compositions different from the extracellular matrix for the internal matrix and the external matrix.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
EP91420137A 1990-04-25 1991-04-25 Sehnenbandprothese und Verfahren zur Herstellung Expired - Lifetime EP0454599B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9005942A FR2661332B1 (fr) 1990-04-25 1990-04-25 Prothese ligamentaire et son procede de fabrication.
FR9005942 1990-04-25

Publications (2)

Publication Number Publication Date
EP0454599A1 true EP0454599A1 (de) 1991-10-30
EP0454599B1 EP0454599B1 (de) 1994-07-27

Family

ID=9396549

Family Applications (1)

Application Number Title Priority Date Filing Date
EP91420137A Expired - Lifetime EP0454599B1 (de) 1990-04-25 1991-04-25 Sehnenbandprothese und Verfahren zur Herstellung

Country Status (5)

Country Link
EP (1) EP0454599B1 (de)
AT (1) ATE109012T1 (de)
DE (1) DE69103076T2 (de)
ES (1) ES2072582T3 (de)
FR (1) FR2661332B1 (de)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995027449A1 (en) * 1994-04-12 1995-10-19 The Secretary Of State For Health In Her Britannic Majesty's Government Of The United Kingdom Of Great Britain And Northern Ireland Cruciate ligament prosthesis
WO2000056275A1 (fr) * 1999-03-22 2000-09-28 Virbac Compositions a base d'un sulfate de chondroïtine et de chitosan pour prevenir ou traiter les affections rhumatologiques par voie generale
WO2001010421A1 (en) * 1999-08-06 2001-02-15 Board Of Regents, The University Of Texas System Drug releasing biodegradable fiber implant
WO2004050134A3 (en) * 2001-11-30 2004-12-09 Cambridge Polymer Group Layered aligned polymer structures and methods of making same
US7048963B2 (en) 2001-11-30 2006-05-23 Cambridge Polymers Group, Inc. Layered aligned polymer structures and methods of making same
US7314860B2 (en) 1997-11-25 2008-01-01 Jenny Ja Antti Wilhurin Rahasto Heparin-like compounds, their preparation and use to prevent arterial thrombosis associated with vascular injury and interventions
US7700147B2 (en) * 2003-01-17 2010-04-20 Lars- Laboratoire D'application Et De Recherche Scientifique Biomimetic prosthetic ligament and production method thereof
AU2004237770B2 (en) * 2003-05-02 2010-08-19 Board Of Regents, The University Of Texas System Drug releasing biodegradable fiber for delivery of therapeutics
CN103315827A (zh) * 2013-06-25 2013-09-25 周婕 一种人工韧带及其制备方法
WO2015197687A1 (fr) 2014-06-25 2015-12-30 Assistance Publique - Hopitaux De Paris Implant amovible pour générer un tendon ou un ligament

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0296078A1 (de) * 1987-06-15 1988-12-21 Centre National De La Recherche Scientifique (Cnrs) Biomaterialien aus Mischungen von Kollagen mit Chitosan und Glycosaminoglykanen, Verfahren zu ihrer Herstellung und ihre Verwendung in der Humanmedizin

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0296078A1 (de) * 1987-06-15 1988-12-21 Centre National De La Recherche Scientifique (Cnrs) Biomaterialien aus Mischungen von Kollagen mit Chitosan und Glycosaminoglykanen, Verfahren zu ihrer Herstellung und ihre Verwendung in der Humanmedizin

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2302029A (en) * 1994-04-12 1997-01-08 Sec Dep For Health Cruciate ligament prosthesis
GB2302029B (en) * 1994-04-12 1997-12-03 Sec Dep For Health Cruciate ligament prosthesis
WO1995027449A1 (en) * 1994-04-12 1995-10-19 The Secretary Of State For Health In Her Britannic Majesty's Government Of The United Kingdom Of Great Britain And Northern Ireland Cruciate ligament prosthesis
US8415324B2 (en) 1997-11-25 2013-04-09 Jenny Ja Antti Wihurin Rahasto Heparin-like compounds, their preparation and use to prevent arterial thrombosis associated with vascular injury and interventions
US7314860B2 (en) 1997-11-25 2008-01-01 Jenny Ja Antti Wilhurin Rahasto Heparin-like compounds, their preparation and use to prevent arterial thrombosis associated with vascular injury and interventions
US7504113B2 (en) 1997-11-25 2009-03-17 Jenny Ja Antti Wihurin Rahasto Heparin-like compounds, their preparation and use to prevent arterial thrombosis associated with vascular injury and interventions
WO2000056275A1 (fr) * 1999-03-22 2000-09-28 Virbac Compositions a base d'un sulfate de chondroïtine et de chitosan pour prevenir ou traiter les affections rhumatologiques par voie generale
FR2791262A1 (fr) * 1999-03-22 2000-09-29 Virbac Sa Compositions a base de chondroitine et de chitosan pour la protection, le traitement ou le remplacement des tissus conjonctifs
US6599888B1 (en) 1999-03-22 2003-07-29 Virbac Chondroitin sulphate and chitosan compositions for treating rheumatic disorders
US8062654B2 (en) 1999-08-06 2011-11-22 The Board Of Regents Of The University Of Texas System Drug releasing biodegradable fiber for delivery of therapeutics
WO2001010421A1 (en) * 1999-08-06 2001-02-15 Board Of Regents, The University Of Texas System Drug releasing biodegradable fiber implant
US7048963B2 (en) 2001-11-30 2006-05-23 Cambridge Polymers Group, Inc. Layered aligned polymer structures and methods of making same
WO2004050134A3 (en) * 2001-11-30 2004-12-09 Cambridge Polymer Group Layered aligned polymer structures and methods of making same
US7700147B2 (en) * 2003-01-17 2010-04-20 Lars- Laboratoire D'application Et De Recherche Scientifique Biomimetic prosthetic ligament and production method thereof
AU2004237770B2 (en) * 2003-05-02 2010-08-19 Board Of Regents, The University Of Texas System Drug releasing biodegradable fiber for delivery of therapeutics
CN103315827A (zh) * 2013-06-25 2013-09-25 周婕 一种人工韧带及其制备方法
CN103315827B (zh) * 2013-06-25 2016-01-20 周婕 一种人工韧带的制备方法
WO2015197687A1 (fr) 2014-06-25 2015-12-30 Assistance Publique - Hopitaux De Paris Implant amovible pour générer un tendon ou un ligament

Also Published As

Publication number Publication date
FR2661332B1 (fr) 1995-06-16
DE69103076T2 (de) 1996-01-11
ATE109012T1 (de) 1994-08-15
FR2661332A1 (fr) 1991-10-31
DE69103076D1 (de) 1994-09-01
EP0454599B1 (de) 1994-07-27
ES2072582T3 (es) 1995-07-16

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